Baylor College of Medicine
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Manager, Regulatory Affairs
role at
Baylor College of Medicine
Summary
The Regulatory Affairs Manager provides analytical, regulatory, and supervisory support for the clinical research/regulatory team at The Center for Cell and Gene Therapy (CAGT). This includes training and supervising regulatory staff, helping investigators develop regulatory strategies, and analyzing regulatory changes affecting CAGT protocols. The Manager works closely with the Director to oversee all aspects of clinical research within CAGT. The role is fast-paced and high-profile, requiring strong concentration, understanding of complex scientific concepts, and multitasking skills. The ideal candidate will be highly organized, intelligent, motivated, and possess strong problem-solving skills.
The position offers a hybrid work schedule. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certifications are eligible for certification pay.
Job Duties
Maintain knowledge of federal regulations, institutional policies, and ICH GCP guidelines to guide regulatory staff and investigators in compliance.
Confirm the content of regulatory submissions.
Collaborate with regulatory staff and investigators on protocol documents and consent forms, and respond to queries from review committees and agencies like the FDA. Submit and maintain required documents.
Assist in preparing for FDA meetings, inspections, and audits.
Maintain systems to communicate regulatory changes and protocol-specific information to relevant parties.
Ensure all clinical research projects remain compliant and are properly documented.
Supervise a team of regulatory professionals.
Perform additional duties as assigned.
Minimum Qualifications
Bachelor's degree.
Four years of relevant experience.
Preferred Qualifications
Master's degree.
Five years in regulatory affairs or compliance.
Experience working with the FDA.
Oncology, Cell, and Gene therapy experience.
Project management skills.
Strong computer and organizational skills.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research
Industry: Higher Education
Location: Houston, TX
Salary Range: $103,000 - $139,000
Note: The job posting is recent and active. No indication of expiration is present.
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Manager, Regulatory Affairs
role at
Baylor College of Medicine
Summary
The Regulatory Affairs Manager provides analytical, regulatory, and supervisory support for the clinical research/regulatory team at The Center for Cell and Gene Therapy (CAGT). This includes training and supervising regulatory staff, helping investigators develop regulatory strategies, and analyzing regulatory changes affecting CAGT protocols. The Manager works closely with the Director to oversee all aspects of clinical research within CAGT. The role is fast-paced and high-profile, requiring strong concentration, understanding of complex scientific concepts, and multitasking skills. The ideal candidate will be highly organized, intelligent, motivated, and possess strong problem-solving skills.
The position offers a hybrid work schedule. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certifications are eligible for certification pay.
Job Duties
Maintain knowledge of federal regulations, institutional policies, and ICH GCP guidelines to guide regulatory staff and investigators in compliance.
Confirm the content of regulatory submissions.
Collaborate with regulatory staff and investigators on protocol documents and consent forms, and respond to queries from review committees and agencies like the FDA. Submit and maintain required documents.
Assist in preparing for FDA meetings, inspections, and audits.
Maintain systems to communicate regulatory changes and protocol-specific information to relevant parties.
Ensure all clinical research projects remain compliant and are properly documented.
Supervise a team of regulatory professionals.
Perform additional duties as assigned.
Minimum Qualifications
Bachelor's degree.
Four years of relevant experience.
Preferred Qualifications
Master's degree.
Five years in regulatory affairs or compliance.
Experience working with the FDA.
Oncology, Cell, and Gene therapy experience.
Project management skills.
Strong computer and organizational skills.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research
Industry: Higher Education
Location: Houston, TX
Salary Range: $103,000 - $139,000
Note: The job posting is recent and active. No indication of expiration is present.
#J-18808-Ljbffr